Releasably-securable one-piece adjustable gastric band

ABSTRACT

A releasably-securable gastric band ( 12 ) having a tail end ( 10   a ) and a head end ( 10   b ) for receiving the tail end ( 10   a ) is disclosed. The gastric band ( 12 ) also includes a releasable locking means ( 20 ) that releasably secures the head ( 10   b ) and tail ends ( 10   a ) together. The tail end ( 10   a ) may include a tooth ( 14 ) and the head end ( 10   b ) may include a notch ( 22 ) for engaging the tooth ( 14 ). Upon insertion of the tail end ( 10   a ) into the head end ( 10   b ), the tooth ( 14 ) mates with the notch ( 22 ) and releasably locks the tail end ( 10   a ) in the head end ( 10   b ). The releasably-securable gastric band ( 12 ) includes a release tab ( 24 ). When force is applied to the release tab ( 24 ) in a direction perpendicular to a central axis of the gastric band ( 12 ), the tooth ( 14 ) is disengaged from the notch ( 22 ) to allow the gastric band ( 12 ) to be released.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to surgically implanted gastricbands for encircling the stomach having a releasable securing appendage.A method for treating morbid obesity utilizing a releasably-securablegastric banding device is also disclosed.

2. Description of the Related Art

A belt-like gastric band for encircling the stomach to control morbidobesity is disclosed by Vincent in U.S. Pat. No. 5,601,604, incorporatedherein by reference. The band comprises a belt that can be passed aroundthe stomach and locked into an encircling position in order to create astoma opening within the stomach. An adjustable portion of the bandcomprises an inflatable member, which permits fine adjustment of thestoma opening after the stoma is created by locking the band in place.The stoma opening may be adjusted by adding or withdrawing a fluid intoor from an inflatable member. The means for injecting the fluid into theinflatable member usually comprises a fill port located beneath the skinthat can be accessed extracorporeally by transdermal injection. Thus,following implantation, the gastric band can be adjusted to enlarge orreduce the stoma as required.

The gastric band is implanted surgically, via laparoscopy or laparotomy,and may involve placement of a calibrating apparatus in the stomach toposition the stoma and size the pouch created above the stoma. Thegastric band is imbricated in position about the stomach to preventslippage, usually by gastro-gastric sutures (i.e. tissue is wrapped overthe band and sutured to itself).

As disclosed by Vincent, the inflatable member or shell is preferablysubstantially coextensive with an inner stomach-facing surface of thegastric band. Furthermore, it has been observed that the inflatablemember should not wrinkle or fold when adjusted, so as to present asubstantially smooth contour along the inner circumference. This ensuresnot only that stomach tissue will not be pinched by the inflatablemember, which could lead to discomfort or necrosis, but also protectsthe shell from a phenomenon known as crease fold failure, which mayoccur if it is inflated beyond its intended range of adjustment or ifthe shell is not formed in a toroidal or circular shape.

In use, it has been observed that current gastric bands cannot be easilyreleased once they are locked in place around the stomach to form thestoma. This can be a significant setback for a surgeon attempting tomove a gastric band after implantation. In particular, a patients'physiology or change in physiology may necessitate moving the band afterinitial placement. Other factors that could require moving or releasingthe band include a patient's inability to control food intake.

In instances where the band has slid out of place, is improperly placed,or where changes in patient physiology require movement of the band, thecurrently known gastric bands do not provide for releasing the lockingmeans that hold the band securely around a patient's stomach. While somedevices may ultimately be releasable, such devices typically requireexertion of considerable force, which can cause damage to or failure ofthe band. Further, when manipulating the band laparoscopically, theamount of force that can be applied during such a procedure is verylimited.

One gastric banding device that appears to have some ability to belocked and unlocked has been marketed under the name HELIOGAST®. TheHeliogast band is an inflatable gastric band having an inflatablelocking means attached to the tail and which is inserted into a loopattached to the head of the band. After implantation, the band must beinflated to lock the band in place. In theory, this band could bere-opened after placement to allow a medical professional to repositionthe band. However, it suffers from the drawback that it must be inflatedto lock into position and therefore it must be deflated before beingopened and moved. The requirement that the band must be inflated to lockalso limits the range of the stoma opening that can be achieved by sucha band, as the band must necessarily have a certain amount of liquidpressure inside the band in order to lock. Consequently, the range ofadjustment of the Heliogast band is limited in comparison with the bandof the present invention, which can be locked regardless of itsinflation level. In addition the band can be opened by application of asmaller force than those of the prior art. The smaller force's abilityto overcome the locking mechanism increases the possibility of the bandunlocking accidentally, such as during vomiting by the patient.

Accordingly, there is a need for a releasable gastric band that can bereleasably locked in place around a patient's stomach, released orunlocked to reposition the gastric band on the patient's stomach (orremove the band altogether), and then secured in place again around thepatient's stomach. There is further a need for a releasably-securablegastric band that does not require deflation before being released, andwhich may be locked in place without subsequent inflation of the lockingmeans. Additionally, there is a need for a gastric band that resistsbeing unlocked by normal physiological forces

There is also a need for an adjustable gastric band with increased easeof use when compared to those currently on the international market,specifically a gastric band that has high tensile force resistance alongthe band, while being able to be opened with reduced force.

Various other objects, advantages and features of the present inventionwill become readily apparent from the ensuing description and the novelfeatures will be particularly pointed out in the appended claims.

SUMMARY OF THE INVENTION

The present invention is directed to a releasably-securable inflatablegastric band having a tail end and a head end for receiving the tailend. The gastric band also includes a releasable locking means thatreleasably secures the head and tail ends together. The tail end mayinclude a tooth and the head end may include a notch for engaging thetooth. Upon insertion of the tail end into the head end, the tooth mateswith the notch and releasably locks the tail end in the head end. Thereleasably-securable gastric band may also include a release tab. Whenforce is applied to the release tab in a direction perpendicular to acentral axis of the gastric band, the release tab acts on the tooth andthe tooth is moved from the notch. This movement of the tooth from thenotch allows the gastric band to open.

The various features of novelty that characterize the invention arepointed out in particularity in the claims annexed to and forming a partof this disclosure. For a better understanding of the invention, itsoperating advantages and specific objects attained by its uses,reference is made to the accompanying descriptive matter in whichpreferred embodiments of the invention are illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a tail end of a gastric band according to thepresent invention;

FIG. 2 is a side view of a head end of a gastric band according to thepresent invention;

FIG. 3 depicts a gastric band according to the present invention havinga smooth inflatable member;

FIG. 4 depicts a fatigue resistant inflatable member of a gastric band;

FIG. 5 depicts a prior art gastric band according to U.S. Pat. No.5,601,604 to Vincent;

FIG. 6 is a perspective view of a gastric band according to the presentinvention showing the head end in the foreground; and

FIG. 7 is a perspective view of a gastric band according to the presentinvention showing the tail end in the foreground.

DETAILED DESCRIPTION

The present invention is directed to a laparoscopic implantableadjustable gastric band designed to be opened or releasedlaparoscopically in order to facilitate repositioning or removal whennecessary. Once locked in position, previously known laparoscopicgastric bands, such as the LAP-BAND®, can only be opened with difficultyand at the risk of damaging the components due to the force required.While particularly suited to laparoscopic implantation, release and/orremoval, the gastric band of the present invention is also suitable forstandard laparotomy procedures.

Turning now to FIGS. 1 and 7, there is shown a tail end 10 a of areleasably-securable gastric band 12. In FIGS. 2 and 6, the head end 10b of gastric band 12 is depicted. The tail end 10 a comprises aelongated tip 18, which may incorporate an inflation tube 30, and asloped tooth 14. Inflation tube 30 has a lumen therethrough to allowfluid to be added to or removed from the an inflatable portion of theband 32 to hydraulically adjust the diameter of the band when it is inan encircling position about the stomach or desired organ. As is wellknown in the art, a stoma of desired size may be by created by adjustingthe diameter of the gastric band. The adjustment may be carried outhydraulically or mechanically. In a hydraulically-adjustable gastricband, inflation tube 30 need not be incorporated into tail end 10 a.Instead, it may be incorporated at head end 10 b or at any point inbetween. Alternatively, gastric band 12 may be adjusted through avariety of known mechanical means. Whether hydraulic or mechanical,gastric band 12 is preferably adjusted via remote control from outsidethe body. Such remote adjustable restriction devices may be activedevices, i.e. powered by implantable sources of energy such asbatteries, capacitors, etc. or passive devices powered from outside thebody by energy transferred through radio frequency, induction,electromagnetic energy, etc.

Turning back to the releasably locking features of the presentinvention, tooth 14 is defined on one side by a notch 16, and mayinclude a visual indicator 38, which will be discussed below inconjunction with the head end 10 b. Also shown in FIG. 1 is theadjustable portion of the band 32. Formed on the head end 10 a of thegastric band 12 is a gripping land 34, which allows the surgeon or othermedical professional to grip the gastric band 12 without fear ofdamaging the fluid bearing portions of the band. The gripping land 34 isespecially helpful when releasing a previously locked gastric band.

The head end 10 b, as shown in FIG. 2, includes a buckle 20 thatreceives and locks the tail end 10 a to form the band in an encirclingposition about the stomach. The buckle 20 has an aperture, or opening,that allows a part of the tail end 10 a to be drawn through the buckle20. The buckle 20 includes a notch 22 for receiving the tooth 14 of thetail end 10 a. The head end 10 b further comprises a release tab 24.Another aspect of the head end 10 b is the indicator window 36, whichallows the surgeon or other medical professional to view the indictor 38portion of the tail end 10 a, preferably enhanced by a contrasting coloror texture, when inserted into the head end 10 b to provide positivevisual and/or tactile indication that the gastric band had beenreleasably locked in position.

In practice, the gastric band is implanted around the stomach of thepatient using now-standard laparoscopic or laparotomic procedures wellknown by those of skill in the gastric banding art. Once the gastricband 12 encircles the stomach and is positioned in the desired locationalong the length of the stomach, the tail end 10 a is inserted into thebuckle 20 of the head end 10 b. A closure tool, such as that describedin U.S. Pat. No. 5,658,298 to Vincent and Coe, the disclosure of whichis incorporated herein by reference, may be used to secure the tail andhead ends, 10 a and 10 b respectively, together. For example, the tailend 10 a is drawn through the buckle 20 until the tooth 14 and the notch22 engage or interlock and prevent the gastric band 12 from opening.When the two ends of the gastric band are properly locked together, theindicator 38 on the tail end 10 a is visible through window 36 on thehead end 10 b. The buckle 20 of the head end 10 b encircles, orsurrounds, the tail end 10 a. The part of the tail end 10 a that isdrawn through and exits the buckle 20 may be identified as a first partof the tail end 10 a, and the part of the tail end 10 a remaining withinthe buckle 20 when the gastric band 12 is releasably secured may beidentified as a second part of the tail end 10 a.

Further elements of the gastric band 12 are the mating recesses 26 and28 of the head and tail ends 10 a and 10 b respectively. These recesses,which are substantially the negative image of one another, butt togetherand prevent the overlap of the two ends of the inner stomach-facingsurface 32 of the gastric band when the band is in its closed position.The recesses 26 and 28 are formed on the head and tail ends respectivelyto ensure a substantially smooth continuous surface contacts thepatient's stomach.

The releasably-securable gastric band according to the present inventionrequires a two-step procedure to release its locking head and tail ends.First the interlocking tooth 14 and notch 20 are disengaged by pullingon the release tab 24 in a direction substantially perpendicular to acentral axis of the now-closed gastric band 12. To assist in pulling onthe release tab 24, the surgeon or other medical professional may alsograsp the gripping land 34 with a second medical instrument. Doing sohelps hold the gastric band 12 in place so that force can be efficientlyapplied to the release tab 24. Next, the tail 10 a may be removed fromthe head end 10 b if the band is to be removed or loosened sufficientlyto allow the gastric band 12 to be repositioned along the length of thepatient's stomach.

Through the use of a slightly elongated head end 10 b, as compared tothe LAP-BAND® of the prior art and U.S. Pat. No. 5,601,604, pulling onthe release tab 24 causes a translational force toward the central axisof the gastric band 12, thereby unlocking and releasing the head andtail ends of the gastric band 12 of the present invention to permitrepositioning or removal of the gastric band 12 without fear of damagingthe gastric band. Both the fit of the tooth 14 and recess 20, and theelasticity of the materials from which the gastric band are made can beoptimized to ensure a sufficiently secure closure of the gastric bandthat requires relatively little force on the release tab 24 to open.

Naturally, geometries other than the tooth 14 and notch 22 may be usedto achieve the ability to releasably secure the band in accordance withthe present invention. One such geometry includes multiple smallerinterlocking elements. Further, the locking elements could be shaped fora “pop-fit” to provide tactile indication that the band is secured inplace or if greater resistance to disengagement is desired.

The present invention may be used in conjunction with a substantiallysmooth adjustable member 32, as shown in FIG. 3, and known in the art.Alternatively, the present invention may be used in conjunction with anewer fatigue-resistant inflatable member 32 a, as shown in FIG. 4. Afatigue resistant band is described in detail in PCT/US03/26678 and isincorporated herein by reference. As described therein, the fatigueresistant inflatable portion 32 a is multi-chambered and resistant towrinkling or folding over its range of adjustment. Like the adjustableportion 32 shown in FIG. 3, the fatigue resistant inflatable portion 32a presents a substantially smooth contour along the inner circumferenceto promote the comfort of the wearer and avoid pinching of the stomachthat can lead to necrosis. The fatigue resistant inflatable member isshown in cross-section in FIG. 4 separate from a complete gastric bandto better illustrate its novel features. As with previous bands, agastric band comprising a fatigue resistant inflatable portion 32 a canbe preformed in a circle, can be locked in place by the surgeon ormedical professional, and in one preferred embodiment is inflated via aninflation lumen running through the tail end 10 a of the gastric band.

Gastric bands according to the present invention may be constructed insequential molding steps, resulting in a fully automated assembly and ahigh degree of precision. Further, the materials from which the gastricband may be made include silicone and other materials known to those ofskill in the art as compatible for implantation within the body.

It will thus be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained and,because certain changes may be made in carrying out the above method andin the construction(s) set forth without departing from the spirit andscope of the invention, it is intended that all matter contained in theabove description and shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

What is claim is:
 1. A releasably-securable adjustable gastric band forthe treatment of obesity suitable for laparoscopic placement around thestomach of a patient, and suitable for laparoscopic removal from saidstomach, comprising: an inflatable portion; a tail end connected to theinflatable portion; a head end, connected to the inflatable portion,having an aperture structured to allow a first part of said tail end tobe drawn through said aperture to position a second part of said tailend within said head end such that said head end encircles said secondpart of said tail end; a releasable locking means including a tooth anda notch structured to engage said tooth to releasably secure said headend to said tail end when said first part of said tail end is drawnthrough said aperture, to thereby releasably secure saidreleasably-securable adjustable gastric band in an encircling positionaround said patient's stomach; a visual securing indicator of acontrasting color or texture; a window through which the visual securingindicator is visible to provide positive visual indication when saidhead end and said tail end are releasably secured together; and arelease tab positioned on said head end and structured to allow saidreleasable locking means to release said tail end from said head endwhen a force is applied to said release tab.
 2. The releasably-securablegastric band of claim 1, wherein said tooth is formed on a portion ofsaid tail end.
 3. The releasably-securable gastric band of claim 2,wherein said notch is in said head end.
 4. The releasably-securablegastric band of claim 1, wherein application of said force to saidrelease tab in a direction substantially perpendicular to a central axisof said releasably-securable adjustable gastric band allows said toothto disengage from said notch so as to allow the release of said tail endfrom said head end.
 5. The releasably-securable gastric band of claim 1,further comprising a tactile securing indicator.
 6. Thereleasably-securable gastric band of claim 1, wherein saidreleasably-securable adjustable gastric band is adjustable via hydraulicinflation.
 7. The releasably-securable gastric band of claim 6, furthercomprising an inflation tube.
 8. The releasably-securable gastric bandof claim 7, wherein said tail end comprises said inflation tube.
 9. Thereleasably-securable gastric band of claim 7, wherein said head endcomprises said inflation tube.
 10. The releasably-securable gastric bandof claim 1, wherein said releasably-securable adjustable gastric band ismechanically adjustable.
 11. The releasably-securable gastric band ofclaim 1, wherein said releasably-securable adjustable gastric band isremotely adjustable.
 12. The releasably-securable gastric band of claim1, wherein application of said force to said release tab lifts saidnotch over said tooth to allow the release of said tail end from saidhead end.
 13. The releasably-securable gastric band of claim 1, whereinan inflation tube comprises said second part of said tail end.
 14. Thereleasably-securable gastric band of claim 1, wherein the position ofthe visual indicator corresponds to the position of only one tooth. 15.The releasably-securable gastric band of claim 14, wherein saidreleasably-securable adjustable gastric band is releasably locked inplace when said visual securing indicator appears in said windowfollowing insertion of said tail end into said head end.
 16. Thereleasably-securable gastric band of claim 1, wherein the appearance ofthe visual indicator through the window corresponds to only the positionof the notch engaged relative to the tooth.
 17. The releasably-securablegastric band of claim 1, wherein the release tab is constructed torelease the tail end from the head end when the force is applied in adirection substantially perpendicular to a central axis of the gastricband.